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EC number: 203-777-6 | CAS number: 110-54-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because there was no GLP statement provided, and limited data on methods were reported, but the study seemed to be well-conducted.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- This study examined the effect of inhalation of n-hexane vapors to fetal development. Groups of 35 pregnant and 10 virgin female mice were exposed to concentrations of 0, 200, 1000, or 5000 ppm of test substance vapors for 20 hrs/day, daily, during gestational days 6 -17. During exposure, females were weighed regularly. At the end of the exposure period, the females were sacrificed, and the uterine contents were examined for parameters including number of live fetuses, number of implantations, and number of resorptions. Fetuses were also examined for malformations.
- GLP compliance:
- no
- Limit test:
- yes
Test material
- Reference substance name:
- N-hexane
- EC Number:
- 203-777-6
- EC Name:
- N-hexane
- Cas Number:
- 110-54-3
- Molecular formula:
- C6H14
- IUPAC Name:
- hexane
- Details on test material:
- - Name of test material (as cited in study report): n-hexane
- Analytical purity: 99.2%
- Lot/batch No.: H-222
- Storage condition of test material: 65 degree F, stored under a blanket of nitrogen
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Raleigh NC
- Weight at study initiation: 28.7-31.5 g
- Housing: cages
- Diet (e.g. ad libitum): NIH-07 diet, ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 73 +/- 3 degrees F
- Humidity (%): 50 +/- 15 %
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure (if applicable):
- whole body
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Battelle-designed chambers, 2.3 m3 stainless steel chambers
- Method of holding animals in test chamber: cages
- Method of conditioning air: Hexane in a 19 l stainless steel reservoir is pumped into delivery tubes to vaporizers at the fresh air inlet to the exposure chambers. The vaporizers are heated to aid in evaporation. Micrometering pumps are used to adjust the concentration.
- System of generating particulates/aerosols:
- Temperature, humidity in air chamber: 73 +/- 3 degree F, 50 +/- 15%
- Air change rate: approx. 15 changes per hour
- Treatment of exhaust air: building exhaust
TEST ATMOSPHERE
- Brief description of analytical method used: Atmosphere was tested using a on-line GC with automatic 8-port sampling valve.
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Atmosphere was tested using a on-line GC with automatic 8-port sampling valve.
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1 male to 1-2 females
- Length of cohabitation: up to five nights
- Proof of pregnancy: vaginal plug referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 20 hrs/day
- Frequency of treatment:
- daily
- Duration of test:
- gestation days 6-17
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 200, 1000, 5000 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 35 pregnant females, 10 virgins per dose
- Control animals:
- yes, sham-exposed
Examinations
- Maternal examinations:
- BODY WEIGHT: Yes
- Time schedule for examinations: plug positive females - days 0, 6, 9, 12, and 18
virgin females - 12 day prior to exosure, days 1, 4 and 7, before sacrifice
POST-MORTEM EXAMINATIONS: Yes / No / No data
- Sacrifice on gestation day 20
- Organs examined: nongravid uteri - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes: half per litter - Statistics:
- SAS statistical software, Duncan's multiple range test
Mean body weigths: SAS General Linear Models Procedure with analysis of variance
Dose response: orthogonal trend test
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Mean weight gain for pregnant females in the 5000 ppm group was significantly reduced compared to controls. There was also a significant reduction in gravid uterine weight in the 200 and 5000 ppm groups. A significant reduction in uterine weight to extra-gestational weight gain was seen in the 5000 ppm group as well. Number of implantations per litter was also reduced in the 5000 ppm group, and also the number of live implants per litter. An increase in intrauterine death was significantly greater only in the 200 ppm group. The incidence of late resorptions was significantly increased in the 5000 ppm group.
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 1 000 ppm
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEC
- Effect level:
- 5 000 ppm
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- LOAEC
- Effect level:
- 200 ppm
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Fetal weights of females in the 5000 ppm group were significantly reduced. The only significant increase in malformations as compared to controls, was an exencephalic fetus in the 5000 ppm group, however, as this was only seen in one fetus, and this malformation was also present in the control group, it is not considered treatment related. Rather it is an anomalous result due to the low background incidence of this malformation.
Effect levels (fetuses)
- Key result
- Dose descriptor:
- LOAEC
- Effect level:
- 200 ppm
- Basis for effect level:
- other: developmental toxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Significant results of mouse developmental toxicity study
Concentration |
0 ppm |
200 ppm |
1000 ppm |
5000 ppm |
Mean body weight – gestational day 18 (g) |
57.0 ± 5.0 |
54.8 ± 4.0 |
55.7 ± 4.9 |
53.7 ± 4.6 |
Uterine mean weight (g) |
21.4 ± 3.8 |
19.2 ± 3.4 |
20.2 ± 3.5 |
17.8 ± 3.9 |
Live fetuses/litter |
12.0 ± 2.6 |
10.6 ± 2.2 |
11.4 ± 2.4 |
10.2 ± 2.7 |
Resorptions/litter |
0.6 ± 0.7 |
1.6 ± 1.7 |
0.8 ± 0.9 |
1.1 ± 1.2 |
Late resorptions/litter |
0.0 ± 0.2 |
0.4 ± 0.9 |
0.4 ± 0.6 |
0.5 ± 0.8 |
% live fetuses/litter |
95.5 ± 5.6 |
87.2 ± 12.2 |
93.5 ± 7.2 |
89.7 ± 12.4 |
% resorptions/litter |
4.5 ± 5.6 |
12.8 ± 12.2 |
6.5 ± 7.2 |
10.3 ± 12.4 |
% late resorptions/litter |
0.3 ± 1.3 |
3.4 ± 6.6 |
2.9 ± 4.6 |
4.5 ± 6.5 |
Female fetal weight (g) |
1.39 ± 0.10 |
1.37 ± 0.10 |
1.35 ± 0.10 |
1.31 ± 0.11 |
% exencephaly/litter affected |
0 ± 0 |
0 ± 0 |
0 ± 0 |
0.5 ± 2.5 |
Applicant's summary and conclusion
- Conclusions:
- The maternal NOAEC was 1000 ppm, and the maternal LOAEC was 5000 ppm based on reduced body weight. The developmental LOAEC was 200 ppm (704 mg/m3) based on increased resorptions and reduced uterine weight. There was no NOAEC for developmental toxicity.
- Executive summary:
This study examined the effect of inhalation of n-hexane vapors to fetal development. Groups of 35 pregnant and 10 virgin female mice were exposed to concentrations of 0, 200, 1000, or 5000 ppm of test substance vapors for 20 hrs/day, daily, during gestational days 6 -17. During exposure, females were weighed regularly. At the end of the exposure period, the females were sacrificed, and the uterine contents were examined for parameters including number of live fetuses, number of implantations, and number of resorptions. Fetuses were also examined for malformations. Body weight was significantly reduced in 5000 ppm exposure females. There was significant reduction in gravid uterine weight in the 200 ppm group, there was also an increase in intrauterine death in this group. Fetal weights were also reduced in the 5000 ppm group. No biologically significant increase in malformations was found. The NOAEC for maternal toxicity is 1000 ppm, and the LOAEC is 5000 ppm based on reduced body weight. There was no NOAEC found for developmental toxicity, and the LOAEC is 200 ppm (704 mg/m3) based on reduced fetal weight gain.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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